A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID

NCT ID: NCT05931432

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 293 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2026-03-01

Brief Summary

For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic.

The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems.

Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources.

Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.

Conditions

Depression, Anxiety; Satisfaction; Well-being

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Usual Care

Participants will be asked to complete an ICF and baseline survey at enrollment. They will be given survey assessments at 0, 18 and 30 months. Survey assessments will include validated measures on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians.

The control group will have access to usual care well-being resources at Penn Medicine. These include links, classes, groups, social media sites such as Penn Cobalt which require self-awareness to find the resources and access them. In this context, the individual has to "pull" the resources they need and there may be several barriers to completing each step

Group Type: NO_INTERVENTION

No interventions assigned to this group

Comprehensive Well-Being Intervention

Participants will be asked to complete an ICF and baseline survey at enrollment. Participants will complete a full assessment using validated instruments at enrollment, 18 months and 30 months (depression, anxiety, stress, resilience, and job satisfaction). Participants will also complete the brief well-being index (WBI, nine questions) every 3 months over 30 months. The primary endpoint is assessed at 18 months. A secondary endpoint of persistence of effect is measured at 30 months.

The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions.

Group Type: EXPERIMENTAL

Comprehensive Well-Being Intervention

Intervention Type: OTHER

The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. The content of monthly text messaging resources and discussion topics for the peer-support groups will be informed by the Aim 1 qualitative findings.

Interventions

Comprehensive Well-Being Intervention

The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. The content of monthly text messaging resources and discussion topics for the peer-support groups will be informed by the Aim 1 qualitative findings.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years of age;
• Interest in participating in an 18 month study and willing to complete regular surveys;
• Regular, daily access to a phone with texting capabilities
• Identify as a Physician at Penn Medicine;

Exclusion Criteria

• Under 18 years of age;
• Not willing to sign informed consent document for an 18 month study;
• No access to a phone with texting capabilities;
• Not a Physician at Penn Medicine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

852022

Identifier Type: -

Identifier Source: org_study_id